D-0539-2023 Class II Ongoing
FDA drug recall D-0539-2023 was initiated by Ascend Laboratories, LLC on March 17, 2023 and is designated Class II. Reason for recall: Out of specification (OOS) for Spectroscopic Identification test by IR. The recall status is ongoing. Affected quantity: 135 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 26, 2023
- Initiation Date
- March 17, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 135 bottles
Product Description
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05
Reason for Recall
Out of specification (OOS) for Spectroscopic Identification test by IR.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #22143120, Exp. Date: June 2024